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Research regulatory compliance / / editors, Mark A. Suckow, Bill J. Yates
| Research regulatory compliance / / editors, Mark A. Suckow, Bill J. Yates |
| Pubbl/distr/stampa | London, England ; ; San Diego, California : , : Academic Press, an imprint of Elsevier, , 2015 |
| Descrizione fisica | 1 online resource (345 p.) |
| Disciplina | 338.97306 |
| Soggetto topico |
Research - Government policy - United States
Research - Moral and ethical aspects Medicine - Research - Moral and ethical aspects |
| ISBN | 0-12-420065-6 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; RESEARCH REGULATORY COMPLIANCE; Copyright; Contents; Contributors; Preface; Chapter 1 - Human Subjects Research Protections; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. KEY REGULATORY AGENCIES AND MANDATE; 4. COMMON CHALLENGES; 5. CURRENT INFLUENCES SHAPING THE FUTURE OF HUMAN RESEARCH SUBJECT PROTECTION; Chapter 2 - Investigational New Drug and Device Exemption Process; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES [1]; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. REGULATORY MANDATES
5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 3 - The Institutional Animal Care and Use Committee; 1. INTRODUCTION; 2. REGULATORY HISTORY; 3. RELEVANT REGULATORY AND OVERSIGHT LAWS, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES FOR THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE; TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; 8. FINAL COMMENTS; Chapter 4 - Biological Hazards and Select Agents; 1. INTRODUCTION 2. HISTORICAL PERSPECTIVES3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; 5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 5 - Radiological Hazards and Lasers; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; 5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES 6. COMMON COMPLIANCE CHALLENGES7. ADDRESSING NONCOMPLIANCE; 8. CONCLUSION; Chapter 6 - Controlled Substances: Maintaining Institutional Compliance; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; DESIGNATED TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 7 - Export Controls and US Research Universities; 1. SUMMARY; 2. KEY DEFINITIONS; 3. INTRODUCTION; 4. HISTORICAL PERSPECTIVES 5. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS6. REGULATORY MANDATES; 7. KEY PERSONNEL AND UNIVERSITY COMMITTEES; 8. COMMON COMPLIANCE CHALLENGES; 9. ADDRESSING NONCOMPLIANCE; Chapter 8 - Data Management and Research Integrity; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; 5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 9 - Intellectual Property 1. SUMMARY |
| Record Nr. | UNINA-9910797243603321 |
| London, England ; ; San Diego, California : , : Academic Press, an imprint of Elsevier, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Research regulatory compliance / / editors, Mark A. Suckow, Bill J. Yates
| Research regulatory compliance / / editors, Mark A. Suckow, Bill J. Yates |
| Pubbl/distr/stampa | London, England ; ; San Diego, California : , : Academic Press, an imprint of Elsevier, , 2015 |
| Descrizione fisica | 1 online resource (345 p.) |
| Disciplina | 338.97306 |
| Soggetto topico |
Research - Government policy - United States
Research - Moral and ethical aspects Medicine - Research - Moral and ethical aspects |
| ISBN | 0-12-420065-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; RESEARCH REGULATORY COMPLIANCE; Copyright; Contents; Contributors; Preface; Chapter 1 - Human Subjects Research Protections; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. KEY REGULATORY AGENCIES AND MANDATE; 4. COMMON CHALLENGES; 5. CURRENT INFLUENCES SHAPING THE FUTURE OF HUMAN RESEARCH SUBJECT PROTECTION; Chapter 2 - Investigational New Drug and Device Exemption Process; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES [1]; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. REGULATORY MANDATES
5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 3 - The Institutional Animal Care and Use Committee; 1. INTRODUCTION; 2. REGULATORY HISTORY; 3. RELEVANT REGULATORY AND OVERSIGHT LAWS, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES FOR THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE; TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; 8. FINAL COMMENTS; Chapter 4 - Biological Hazards and Select Agents; 1. INTRODUCTION 2. HISTORICAL PERSPECTIVES3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; 5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 5 - Radiological Hazards and Lasers; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; 5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES 6. COMMON COMPLIANCE CHALLENGES7. ADDRESSING NONCOMPLIANCE; 8. CONCLUSION; Chapter 6 - Controlled Substances: Maintaining Institutional Compliance; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; DESIGNATED TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 7 - Export Controls and US Research Universities; 1. SUMMARY; 2. KEY DEFINITIONS; 3. INTRODUCTION; 4. HISTORICAL PERSPECTIVES 5. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS6. REGULATORY MANDATES; 7. KEY PERSONNEL AND UNIVERSITY COMMITTEES; 8. COMMON COMPLIANCE CHALLENGES; 9. ADDRESSING NONCOMPLIANCE; Chapter 8 - Data Management and Research Integrity; 1. INTRODUCTION; 2. HISTORICAL PERSPECTIVES; 3. RELEVANT REGULATORY/OVERSIGHT AGENCIES, REGULATIONS, AND GUIDANCE DOCUMENTS; 4. KEY REGULATORY MANDATES; 5. KEY PERSONNEL AND UNIVERSITY COMMITTEES DESIGNATED TO IMPLEMENT REGULATORY MANDATES; 6. COMMON COMPLIANCE CHALLENGES; 7. ADDRESSING NONCOMPLIANCE; Chapter 9 - Intellectual Property 1. SUMMARY |
| Record Nr. | UNINA-9910821546803321 |
| London, England ; ; San Diego, California : , : Academic Press, an imprint of Elsevier, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||